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Clinical trial

The Impact of Slow, Continuous Infusion of Sodium Chloride or Glucose Solution on Diuresis and Urine Composition During Decongestion of Acute Heart Failure Patients

ID
Name
KB-68/2022
Description
The aim of the study is to compare the differences in diuretic, natriuretic and clinical response to decongestion in patients receiving different replacement fluid regimens (0.9% sodium chloride vs 5% glucose) in acute heart failure.
Trial arms
Trial start
2022-02-01
Estimated PCD
2023-12-01
Trial end
2024-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Furosemide intravenous infusion
At baseline, patients will receive a standardised dose of furosemide 1mg/kg (half of the dose administered as bolus and half as in 2h infusion). At the 6th and the 12th hour of the study patients will be reassessed and the need for additional diuretics.
Arms:
0.9 % Sodium Chloride solution, 5% Glucose solution
Continous intravenous infusion of 0.9% Sodium Chloride solution
Continuous 48h infusion of 0.9% sodium chloride at a fixed rate v= 83 ml/h x 24h = 2l/24h
Arms:
0.9 % Sodium Chloride solution
Continous intravenous infusion of 5% Glucose solution
Continuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h
Arms:
5% Glucose solution
Size
50
Primary endpoint
Urine volume change at individual timepoints during first day of the procedure.
24 hours
Urine volume change at individual timepoints during second day of the procedure.
48 hours
Urine composition at individual time points.
72 hours
Cumulative urine output at 24 hours.
24 hours
Cumulative urine output at hours.
48 hours
Total dose of furosemide.
48 hours
Eligibility criteria
Inclusion Criteria: * patients \>18 years old who sign the informed consent * the primary cause of hospitalization is Acute Heart Failure with a need for intravenous Furosemide * the start of the study within 24h of hospital admission Exclusion Criteria: * need for inotropic support * end stage renal disease on dialysis * serum sodium \> 148mmol/l or \< 130 mmol/l.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-07-27

1 organization

3 products

3 indications

Organization
Wroclaw Medical University
Product
Furosemide
Indication
Acute Heart Failure
Indication
Upper respiratory congestion
Indication
Congestive Heart Failure
Product
Sodium Chloride
Product
5% Glucose